The invention relates to a reusable container for the transfer of sterile pharmaceutical recipients. The invention further relates to a transfer system for the sterile transfer of pharmaceutical recipients and also to a method for filling pharmaceutical recipients with at least one pharmaceutical medium. Containers, transfer systems and methods of this type may be used in particular in the field of the manufacture and/or bottling of pharmaceutical recipients, such as, for example, medicaments, diagnostic agents or the like. However, as a matter of principle, the invention can also be used in other sectors requiring a transfer of any type of low-germ or sterile recipients, for example in the fine chemicals sector or in the food industry sector.
The transfer of recipients under sterile conditions is important in many areas of natural science and technology. Examples of this include, as stated above, pharmaceutical production or bottling in which medicinal products (for example, pharmaceutical agents, pharmaceutical composition preparations, diagnostic agents, diagnostic agent-containing preparations and/or therapeutic media) are poured into suitable recipients. A further possible area of application is the treatment or handling of biological samples. Further areas are the foodstuff industry which also requires at least a low germ count. Pharmaceutical production will be described hereinafter without restricting possible further applications of the invention.
In the pharmaceutical industry, a large number of bottling technologies are used for manufacturing in particular filled single-use syringes, known as ready-to-use syringes, under aseptic, i.e., at least largely germ-free, conditions. As a matter of principle, a distinction is drawn in this case between what are known as line filler technologies and what are known as tray filler technologies, although further bottling techniques can also be used. The present invention relates in particular to tray filler technologies, but can also be used for other bottling technologies, for example line filler technology.
In tray filler technology, unfilled, initially non-sterile syringe bodies (what are known as ready-to-fill syringe bodies) are introduced at a packaging supplier's factory into what are known as trays which are conventionally made of plastics material. The trays are in this case conventionally embodied as upwardly open shells having a raised edge. These trays are equipped with internal plastics material racks (also referred to as a nest) into which the previously cleaned and closed-tipped syringe bodies are inserted with the tip hanging downward. The trays with the racks and the syringe bodies are then generally covered or closed with a plurality of layers of foils which are loose or welded to the tray (a type of shell) and subsequently sterilized generally with ethylene oxide or if appropriate other methods. The multiple covering or closing prevents microbial contamination after the sterilization. The sterile syringe bodies packaged in this way in the trays are then delivered to the pharmaceutical agent manufacturer and/or the bottling factories. There, the trays are opened for filling the syringe bodies under aseptic clean room and handling conditions and the syringe bodies are generally brought together with the tray and rack to a special bottling machine (tray filler machines). There, the syringes are then filled and closed after filling—generally while still in the tray or rack or nest. The filled, closed syringes are subsequently, during what is known as “de-nesting”, removed from the trays, generally by machine, and further processed. The trays and racks are left behind, as are the protective foils, all of which are generally not reused and constitute considerable waste.
An example of a document describing conventional bottling technologies of this type is DE 44 19 475 A1. Said document describes methods which relate in particular to tray filler technology and reference may be made to said document for further details of possible bottling processes and tray filler technology. DE 44 19 475 A1 discloses a means for removing the covering of storage boxes, such as can, for example, be used as trays in tray filler technology.
However, DE 44 19 475 A1 already makes some of the drawbacks of known technologies apparent. Thus, the large-scale handling of the previously used, welded trays equipped with a plurality of protective foils is extremely costly. Special devices, such as, for example, the device described in DE 44 19 475 A1, have to be used in order to open the outer packagings of the sterilized syringe bodies and in order to remove the nests from the trays.
Furthermore, the trays equipped with as-yet-unfilled syringe bodies (or if appropriate other primary packagings) take up a lot of storage space. Furthermore, special bottling machines (tray fillers) are required that are specially designed for filling the syringe bodies which reach the bottling station in the trays.
A further drawback of the above-described method, which is becoming increasingly important, is the large amount of waste incurred in this method. Thus, the single-use outer packagings, which are disposed of after the removal of the syringe bodies or the trays, are valuable raw materials which are generally wasted without being re-used. This not only constitutes a considerable cost factor, but can also cause considerable environmental problems in large-scale bottling operations.
US 2003/0235511 A1 describes a method for sterilization by means of chemical vapors. This method uses a sterilization chamber which is connected to a vacuum pump and a vaporizer. The articles to be sterilized are inserted in trays or containers. The trays or containers are then encased with a material which is permeable to the sterilizing vapors. This method thus also has the above-described drawbacks that the method is associated with a large amount of waste and for large-scale use would require costly devices which remove the casings.
A further important point in a large-scale implementation of bottling technologies is the reversibility of the methods. If for example the bottling, be it in a line filler or in a tray filler installation, has to be briefly interrupted, for example on account of technical malfunctions, then it should be readily possible to return the recipients to be filled to the transfer container used and to temporarily store them there without the recipients thereby becoming contaminated and without costly devices being required for this purpose. The above-described methods of DE 44 19 475 A1 or US 2003/0235511 A1 do not satisfy these requirements, as in this method a costly renewed casing would be required during a return to the containers.
DE 1 017 454 A proposes a method for the sterile packaging of liquids, in particular milk, in which presterilized packaging material is supplied in closed containers in the form of cartridges to a sterile cabin. In this case, a closed removal end of the cartridge is coupled to a likewise initially closed entrance opening to the sterile cabin for the packaging material via a separately sterilizable coupling space which is closed on all sides. By way of example, said document states how the packaging material in the form of cups, which can be placed one inside another, is accommodated in the cartridge. However, this method is not suitable either for ensuring the above-described temporary storage in the event of an interruption to the bottling process, as the described process of accommodating in cartridges in many cases does not allow the removal to be reversed. In addition, although the described cartridges are suitable for milk recipients, they can lead in the case of sensitive glass recipients, which usually cannot be placed one inside another, to damage and even soiling caused by splinters of glass.